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Nebulization composition comprising tiotropium and indacaterol

a technology of tiotropium and indacaterol, which is applied in the direction of organic active ingredients, respiratory disorders, pharmaceutical non-active ingredients, etc., can solve the problems of difficult patient breathing, clogging of airways, life-threatening, etc., and achieves convenient, fast and reliable treatment, the effect of improving user compliance and/or quality of li

Inactive Publication Date: 2020-07-09
GLENMARK SPECIALTY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The present invention provides a nebulization composition that can increase the forced expiratory volume (FEV1) in patients with asthma or COPD. This method is convenient, fast, and reliable, and can improve user compliance and quality of life in patients with asthma or COPD as compared to traditional treatments. The technical effect of the invention is to offer a better treatment option for inflammatory and obstructive airway diseases such as COPD and asthma.

Problems solved by technology

Asthma and chronic obstructive airway disease (COPD) are among the most prevalent and life threatening conditions.
All of these effects lead to clogging of the airways making it difficult for the patient to breathe.
Indacaterol is characterized by low aqueous solubility, classified as “very slightly soluble in water.” This poses a serious challenge to solubilizing indacaterol.

Method used

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  • Nebulization composition comprising tiotropium and indacaterol
  • Nebulization composition comprising tiotropium and indacaterol

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0157]

Amount in %w / v#12345678Tiotropium0.0001-0.008bromideIndacaterol0.0003-0.064maleateSodium0.90.90.9 0.90.9 0.9 0.90.9chlorideCitric acid1.9231.9230.9613.845 1.923 1.923——monohydrateTrisodium0.250.250.1250.50.250.25——citratedihydrateEdetate0.01-0.02—————0.01-0.020.01-0.02disodiumHCl———————q.s.Polysorbate 20————0.02———Polysorbate 80—————0.02——Sodium—————— 0.94—dihydrogenphosphatedihydrateAnhydrous—————— 0.175—disodiumhydrogenphosphateWater forq.s.q.s.q.s.q.s.q.s.q.s.q.s.q.s.injection

Manufacturing Process

[0158]1. Dissolve sodium chloride, edetate disodium, citric acid monohydrate, trisodium citrate dihydrate or sodium dihydrogen phosphate dihydrate, and anhydrous disodium hydrogen phosphate in water for injection with stirring. Add hydrochloric acid to adjust the pH (composition #8).[0159]2. Check the clarity of the solution.[0160]3. Add indacaterol maleate (optionally dissolved in Polysorbate 20 or Polysorbate 80) to the product of step 1 with stirring.[0161]4. Sonicate until a cl...

example 2

[0165]

Amount in μg / 2 ml#1234Tiotropium 5-40 μg / 2 mlbromideIndacaterol10-300 μg / 2 mlmaleateSodium chloride16000160001600016000Tartaric acid5000500050005000Monosodium Citrate2000200020002000Edetate disodium200—200—Benzalkonium Chloride400400——Water for injectionq.s. 2 mlq.s. 2 mlq.s. 2 mlq.s. 2 ml

Manufacturing Process

[0166]1. Dissolve batch quantities of sodium chloride, edetate disodium, tartaric acid and monosodium citrate in water for injection with stirring. Check the clarity of the solution.[0167]2. Add indacaterol maleate to the product of Step 1.[0168]3. Stir / homogenize / sonicate until a clear solution is obtained.[0169]4. Add tiotropium bromide to the product of Step 3 with stirring.[0170]5. Add benzalkonium chloride (BKC) to the product of Step 4 and mix. Make up the volume with water for injection.[0171]6. Filter the product of Step 5 through a sterilizing grade filter.[0172]7. Fill the product of Step 6 in LDPE smartules / HDPE, PP, LDPE bottles / amber glass bottles / amber glass...

example 3

[0173]

Amount in μg / 2 ml#1234Tiotropium 5-40 μg / 2 mlbromideIndacaterol10- 300 μg / 2 mlmaleateSodium chloride16000160001600016000Tartaric acid5000500050005000Sodium tartrate2000200020002000dihydrateEdetate disodium200—200—Benzalkonium chloride400400——Water for injectionq.s. 2 mlq.s. 2 mlq.s. 2 mlq.s. 2 ml

Manufacturing Process

[0174]1. Dissolve batch quantities of sodium chloride, edetate disodium, tartaric acid and sodium tartrate dihydrate in water for injection with stirring. Check the clarity of the solution.[0175]2. Add indacaterol maleate to the product of Step 1.[0176]3. Stir / homogenize / sonicate until a clear solution is obtained.[0177]4. Add tiotropium bromide to the product of Step 3 with stirring.[0178]5. Add benzalkonium chloride (BKC) to the product of Step 4 and mix. Make up the volume with water for injection.[0179]6. Filter the product of Step 5 solution through sterilizing grade filter.[0180]7. Fill the product of Step 6 in LDPE smartules / HDPE, PP, LDPE bottles / amber glas...

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Abstract

This disclosure relates to a nebulization composition comprising tiotropium, or a pharmaceutically acceptable salt thereof, and indacaterol, or a pharmaceutically acceptable salt thereof. This disclosure also relates to a process for preparing such a composition and to methods of treating inflammatory and / or obstructive airway diseases using such a composition.

Description

CROSS REFERENCE TO RELATED APPLICATIONS[0001]This application claims priority to Indian Provisional Patent Application No. 201921000273 filed on Jan. 3, 2019 and Indian Provisional Patent Application No 201921041250 filed on Oct. 11, 2019, the entire contents of which are incorporated by reference herein.FIELD OF THE INVENTION[0002]The present invention relates to a nebulization composition comprising tiotropium, or a pharmaceutically acceptable salt thereof, and indacaterol, or a pharmaceutically acceptable salt thereof. The present invention also relates to a process for preparing such a composition and to methods of treating inflammatory and / or obstructive airway diseases using such a composition.BACKGROUND OF THE INVENTION[0003]Respiratory disorders include a number of airway diseases. Asthma and chronic obstructive airway disease (COPD) are among the most prevalent and life threatening conditions.[0004]COPD is a chronic disorder characterized by loss of elasticity of the airway...

Claims

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Application Information

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IPC IPC(8): A61K31/4704A61K31/439A61K9/08A61K9/00A61K47/02A61K47/12
CPCA61K9/0078A61K47/12A61K47/02A61K9/08A61K31/4704A61K31/439A61K9/12A61P11/08A61K2300/00
Inventor KULKARNI, SUSHRUTCHAUDHARI, SUNILRAJURKAR, SURESHYEWALE, CHETANANKAM, RAJESHDHUPPAD, ULHAS
Owner GLENMARK SPECIALTY
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